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    Summary
    EudraCT Number:2019-004461-41
    Sponsor's Protocol Code Number:MET59
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-02-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-004461-41
    A.3Full title of the trial
    Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Immune Response after a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Alone or Concomitantly with a Licensed Meningococcal Serogroup B Vaccine,in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
    A.4.1Sponsor's protocol code numberMET59
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04084769
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1217-2137
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/164/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi Pasteur Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur Inc
    B.5.2Functional name of contact pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street AddressDiscovery Drive
    B.5.3.2Town/ citySwiftwater
    B.5.3.3Post codePA 18370-0187
    B.5.3.4CountryUnited States
    B.5.6E-mailContact-US@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMenACYW conjugate vaccine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup A Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup C Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    D.3.9.4EV Substance CodeSUB31471
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup Y Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup W Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Trumenba®
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Pharmaceuticals, Inc, a subsidiary of Pfizer Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTrumenba
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis serogroup B fHbp subfamily A
    D.3.9.3Other descriptive nameMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY A PROTEIN
    D.3.9.4EV Substance CodeSUB31503
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis serogroup B fHbp subfamily B
    D.3.9.3Other descriptive nameMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY B PROTEIN
    D.3.9.4EV Substance CodeSUB31504
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bexsero®
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Vaccines, Srl
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBexsero
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOuter membrane vesicles from N meningitidis group B
    D.3.9.3Other descriptive nameOUTER MEMBRANE VESICLES FROM NEISSERIA MENINGITIDIS GROUP B (STRAIN NZ 98/254)
    D.3.9.4EV Substance CodeSUB77057
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Neisseria (N) meningitidis group B
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96088
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant N meningitidis group B fHbp fusion protein
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96090
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant N meningitidis group B NadA protein
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96089
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y and W)
    E.1.1.1Medical condition in easily understood language
    Invasive meningococcal disease (IMD)
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027274
    E.1.2Term Meningococcal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW conjugate vaccine in subjects who were first vaccinated with 1 dose of MenACYW conjugate vaccine or Menveo vaccine 3-6 years before the booster dose (Groups 1 and 2)
    E.2.2Secondary objectives of the trial
    To describe:
    -vac seroresponse, seroprotection: serum bactericidal assay using human complement [hSBA] titer ≥1:8 and Ab responses [GMTs] of meningococcal serogroups ACYW measured using hSBA in serum specimens collected 6 d ±1 after vaccination in a subset of 50 subj per gr(1,2)
    -vac serorespns, seroprotct and Ab resp to serogrp ACYW on D0 pre-vacc and D30 +14d after vacc with MenACYW conju vac alone (1,2)
    -Ab persistence of meningococcal serogrp ACYW before a booster dose in subj who received either MenACYW conju vac or Menveo vac 3-6 y earlier
    -Ab persistence of meningococcal serogrp ACYW in subj who received either a single dose MenACYW conju vac subj rdmzd to MET59 Gr1,3,4 or Menveo vac: subj assigned to MET59 Gr 2 as part of MET50 or MET43: subj randomized to MET59 Gr1,3 and 4
    -vac seroresponse, seroprotection and Ab responses to the Ag present in MenACYW conju vac, when MenACYW conju vac is given concomitantly with MenB vac(3,4) compared to those when it is given alone (1)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged ≥ 13 to < 26 years on the day of inclusion
    - Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only)
    - For Group 2 only (Menveo vaccine-primed participants only; enrichment population): participants have a documented record of having received 1 dose of Menveo vaccine 3-6 years earlier either as part of a clinical trial or as routine vaccination. Participants who participated in MET50 Group 4 can be enrolled if they fulfill this criterion
    - Participants aged 13 to < 18 years: assent form has been signed and dated by the participant and informed consent form (ICF) has been signed and dated by the parent or guardian
    - Participants aged ≥ 18 (or legal age of majority, if different from 18 years of age) to < 26 years: ICF has been signed and dated by the participants
    - Participant aged 13 to < 18 years: both the participant and parent or guardian are able to attend all scheduled visits and to comply with all trial procedures
    - Participants aged ≥ 18 (or legal age of majority, if different from 18 years of age) to < 26 years: able to attend all scheduled visits and to comply with all trial procedures
    E.4Principal exclusion criteria
    - Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
    - Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
    - Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine before Visit 3 except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccine
    - Receipt of immune globulins, blood or blood-derived products in the past 3 months
    - Receipt of any meningococcal vaccine including a licensed or investigational MenACWY vaccine or MenB vaccine since participation in study MET50 or MET43
    - Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of more than 1 dose of Menveo vaccine or vaccination with another licensed or investigational MenACWY vaccine or with a licensed or investigational MenB vaccine
    - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
    - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
    - At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease)
    - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
    - Personal history of Guillain-Barré syndrome (GBS)
    - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination
    - Verbal report of thrombocytopenia, contraindicating intramuscular vaccination
    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
    - Current alcohol abuse or drug addiction
    - Chronic illness (eg, HIV, hepatitis B, hepatitis C) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
    - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
    - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
    - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers equal or greater than (≥) 1:16 for participants with pre-vaccination titers lower than (<) 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30 (post-vaccination)
    E.5.2Secondary end point(s)
    1 - Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
    2 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
    3 - Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
    4 - Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
    5 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
    6 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
    7 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
    8 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
    9 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
    10 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
    11 - Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1, Group 3 and Group 4 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
    12 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1, Group 3 and Group 4 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
    13 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W: Group 1, Group 3 and Group 4 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3: Day 6 (post-vaccination)
    4, 5, 6, 9, 10, 11, 12, 13: Day 0 (pre-vaccination) and Day 30 (postvaccination)
    7, 8: Day 0 (pre-vaccination)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Day 180 safety follow-up telephone call (approximately 6 months after vaccination).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 300
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 300
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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